10 reasons why you should consider certified medical devices

SilverFit systems are certified medical devices which comply with the requirements of various international standardisation bodies: SilverFit medical products comply with the new MDR (Medical Device Regulation) requirements for CE (Conformité Européenne) marking; SilverFit medical products are developed in compliance with the IEC (International Electrotechnical Commission) 62304 standards for medical software. Our working methods are […]

CE mark according to MDR for SilverFit systems

As of 24 May, 2024 European regulations for medical devices have changed. SilverFit’s medical products meet these new MDR requirements for CE marking. Our way of working follows standards for medical products such as ISO 13485 for quality management (certified) and IEC 62304 for software development (not certified) among others. . This means, for example […]

Update SilverFit Newton

For this update, 6 games have been added to stimulate a client’s cognition during strength training. These games are suitable for improving memory, planning, arithmetic skills, spatial awareness, situational assessment, and language proficiency. These games can be found under ‘Train dynamicly’. Here are some of the new excercises: Spelling bee: A word or picture is […]